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Treatment for Pain

ALZA Corporation Resubmits U.S. New Drug Application for IONSYS (Fentanyl HCl Patient-Activated Transdermal System)

MOUNTAIN VIEW, Calif., November 28, 2005 -- ALZA Corporation, a wholly owned subsidiary of Johnson & Johnson, today announced that in response to an approvable letter from the U.S. Food and Drug Administration received in mid-2004, it has resubmitted a New Drug Application (NDA) for IONSYS (Fentanyl hydrochloride (HCl) Patient-Activated Transdermal System (PATS) 40 mcg/dose). IONSYS is an investigational iontophoretic transdermal system for acute postoperative pain.

IONSYS is the first product in development to incorporate the proprietary E-TRANS(R) iontophoretic transdermal drug delivery system developed by ALZA. The system delivers drug systemically by using low-level electrical energy to actively transport drugs through intact skin. The active ingredient of IONSYS is an opioid analgesic, fentanyl hydrochloride.

ALZA originally submitted the application for licensure of IONSYS to the FDA in September 2003. If the NDA resubmission is accepted as satisfying the requirements for a complete response, the FDA could complete its review within six months, under the Prescription Drug User Fee Act (PDUFA). Pending FDA approval, IONSYS will be marketed in the United States by Ortho- McNeil, Inc, a wholly owned subsidiary of Johnson & Johnson.

IONSYS also is awaiting approval in the European Union. This October, the European Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, adopted a positive opinion recommending marketing authorization for the product in the 25 member states of the European Union. If approved, the product will be marketed throughout the European Union by Janssen-Cilag companies, also Johnson & Johnson affiliates.

Posted: November 2005

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